Type 1 DiabetesNCT02862730
Four Way Crossover Closed Loop With Exercise Detection
A study testing Subject's insulin pump in people with Type 1 Diabetes, run by Oregon Health and Science University at 1 site in United States.
Trial summary
Closed-loop systems are an emerging technology that automate hormone delivery. They are quickly paving the way to revolutionize the treatment of type 1 diabetes. Several categories have emerged: dual-hormone (insulin and glucagon) closed-loop systems and closed-loop systems with insulin only, one variety of which is… Read more about this study
- Who is it for?
- Ages 21 to 45 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Subject's insulin pump
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2016to 31 Jan 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosis of type 1 diabetes mellitus for at least 1 year.
- Physically willing and able to perform 45 min of exercise (as determined by the investigator after reviewing the subjects activity level)
- Current use of an insulin pump.
- Lives with another person age 18 or older who will be present while subject exercises at home and that can attend the training on using the system with the subject.
- Lives within 20 miles of OHSU.
- A1C<10%
- Willingness to follow all study procedures, including attending all clinic visits.
- Willingness to sign informed consent and HIPAA documents.
Who cannot join
- Female of childbearing potential who is pregnant or intending to become pregnant or breast-feeding, or is not using adequate contraceptive methods. Acceptable contraception includes birth control pill / patch / vaginal ring, Depo-Provera, Norplant, an IUD, the double barrier method (the woman uses a diaphragm and spermicide and the man uses a condom), or abstinence.
- Any cardiovascular disease, defined as a clinically significant EKG abnormality at the time of screening or any history of: stroke, heart failure, myocardial infarction, angina pectoris, or coronary arterial bypass graft or angioplasty. Diagnosis of 2nd or 3rd degree heart block or any non-physiological arrhythmia judged by the investigator to be exclusionary.
- Renal insufficiency (GFR < 60 ml/min, using the MDRD equation as report by the OHSU laboratory).
- Liver failure, cirrhosis, or any other liver disease that compromises liver function as determined by the investigator.
- Hematocrit of less than or equal to 34%.
- Hypertensive subjects with systolic blood pressure >= 160 mmHg or diastolic blood pressure >= 100 mmHg despite treatment or who have treatment-refractory hypertension (e.g. requiring four or more medications).
Show all 33Show fewer
- History of severe hypoglycemia during the past 12 months prior to screening visit or hypoglycemia unawareness as judged by the investigator. Subjects will complete a hypoglycemia awareness questionnaire. Subjects will be excluded for four or more R responses.
- Adrenal insufficiency.
- Any active infection.
- Known or suspected abuse of alcohol, narcotics, or illicit drugs.
- Seizure disorder.
- Active foot ulceration.
- Severe peripheral arterial disease characterized by ischemic rest pain or severe claudication.
- Major surgical operation within 30 days prior to screening.
- Use of an investigational drug within 30 days prior to screening.
- Chronic usage of any immunosuppressive medication (such as cyclosporine, azathioprine, sirolimus, or tacrolimus).
- Bleeding disorder, treatment with warfarin, or platelet count below 50,000.
- Allergy to aspart insulin.
- Allergy to glucagon.
- Insulin resistance requiring more than 200 units per day.
- Need for uninterrupted treatment of acetaminophen.
- Current administration of oral or parenteral corticosteroids.
- Any life threatening disease, including malignant neoplasms and medical history of malignant neoplasms within the past 5 years prior to screening (except basal and squamous cell skin cancer).
- Beta blockers or non-dihydropyridine calcium channel blockers.
- Current use of any medication intended to lower glucose other than insulin (ex. use of liraglutide).
- Diagnosis of pheochromocytoma, insulinoma, or glucagonoma, personal or family history of multiple endocrine neoplasia (MEN) 2A, MEN 2B, neurofibromatosis or von Hippel-Lindau disease.
- History of severe hypersensitivity to milk protein.
- Current use of any medication with strong anticholinergic properties, such as antihistamines, sleep aids, and antidiarrheal medications.
- Current use of indomethacin.
- Conditions that may result in low levels of releasable glucose in the liver and an inadequate reversal of hypoglycemia by glucagon such as prolonged fasting, starvation or chronic hypoglycemia as determined by the investigator.
- A positive response to any of the questions from the Physical Activity Readiness Questionnaire.
- Any chest discomfort with physical activity, including pain or pressure, or other types of discomfort.
- Any clinically significant disease or disorder which in the opinion of the Investigator may jeopardize the subject's safety or compliance with the protocol.
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health and Science University
Portland, Oregon, 97239
About this study
Official title: A Randomized, Four-way, Cross-over Outpatient Study to Assess the Efficacy of a Dual-hormone Versus Insulin Alone Closed-loop System With Exercise Detection vs a Predictive Low Glucose Suspend System vs Current Care
Closed-loop systems are an emerging technology that automate hormone delivery. They are quickly paving the way to revolutionize the treatment of type 1 diabetes. Several categories have emerged: dual-hormone (insulin and glucagon) closed-loop systems and closed-loop systems with insulin only, one variety of which is the low glucose suspend safety feature now available from Medtronic (MiniMed 530G with Enlite). The study described within this protocol is designed to test the efficacy of a new closed-loop algorithm for managing blood glucose in people with type 1 diabetes before and after exercise. The new algorithm will have 3 modes: a single hormone insulin only mode, a dual-hormone insulin and glucagon mode and an insulin only mode with predictive low glucose suspend, all with an exercise detection algorithm. The purpose of this study is to determine whether a dual hormone AP with an exercise detection algorithm outperforms both single hormone AP and a low glucose suspend algorithm and sensor augmented pump therapy using the subject's own insulin pump.
Read the detailed description
Subjects will undergo four approximately 84 hour studies. The first day of each study will be an approximately 12 hour inpatient visit to include activities of daily living and an exercise period with 2 days spent as an outpatient. The subject will come back to the research center on the fourth day to complete another approximately 12 hour inpatient visit to include activities of daily living and an exercise period followed by removal of all devices. In randomized order, subjects will have glucose controlled using the following systems: 1) dual-hormone closed-loop system, 2) insulin only closed-loop system, 3) predictive low glucose suspend system and 4) sensor augmented pump therapy with subject using their own insulin and insulin pump. Both of the closed-loop system algorithms have an exercise detection algorithm that uses inputs from a heart rate monitor and accelerometer, the Zephyrlife BioPatch. After exercise detection, insulin is turned off for the first 30 minutes, the total insulin infusion rate is adjusted by an exercise multiplier, and for the dual-hormone system, the target glucose for glucagon is increased along with the maximum dose of glucagon allowed. The predictive low glucose suspend system will utilize the patient's optimized basal rates, correction factor, and carb ratio. The patient will bolus for meals and hyperglycemia as usual under PLGS, but will have the additional safety net of the pump suspending insulin when it predicts a hypoglycemic event. The Dexcom CGM system and the Tandem t:slim pumps will be used for all three intervention visits.
Subjects will arrive at the CTRC at 7am at the start of intervention visits. Subjects will eat breakfast, lunch and dinner in the research center. Subjects will eat breakfast at 8:30am. After breakfast, subjects will complete activities of daily living (sitting on a chair, lying on a bed, washing dishes, sweeping the floor, etc.). Subjects will eat lunch at 12pm. Subjects will exercise for 45 minutes on a treadmill around 2pm. Subjects will eat dinner at 6pm and be discharged. The subject will then go home for Day 2 and Day 3 and return on Day 4 to complete another 12 hour inpatient visit with the schedule of activities identical to Day 1.
- Conditions
- Type 1 Diabetes
- Being tested
- Artificial Pancreas Controller in Dual Hormone Mode, Subject's insulin pump, Artificial Pancreas Controller in Single Hormone Mode, Artificial Pancreas Controller in Predictive Low Glucose Suspend Mode
- Keywords
- diabetes, closed-loop, dual hormone, exercise
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artificial Pancreas Controller in Dual Hormone ModeDevice
Also called APC
The artificial pancreas controller contains an algorithm for managing blood glucose in people with type 1 diabetes which includes an exercise detection component. The new algorithm will have 3 modes: a single hormone closed-loop insulin only mode, a dual-hormone closed-loop insulin and glucagon mode and an insulin only mode with predictive low glucose suspend. Closed-loop Artificial Pancreas Controller includes insulin and glucagon delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to two Tandem t:slim insulin pumps, one filled with insulin and one with glucagon.
Subject's insulin pumpDevice
Subject will continue on their subcutaneous delivery of insulin on his/her own insulin pump using their own basal rates and carb ratios for meal boluses, managing their blood sugar as they normally would.
Artificial Pancreas Controller in Single Hormone ModeDevice
The artificial pancreas controller contains an algorithm for managing blood glucose in people with type 1 diabetes which includes an exercise detection component. The new algorithm will have 3 modes: a single hormone closed-loop insulin only mode, a dual-hormone closed-loop insulin and glucagon mode and an insulin only mode with predictive low glucose suspend. Closed-loop Artificial Pancreas Controller includes insulin delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to one Tandem t:slim insulin pumps filled with insulin.
Artificial Pancreas Controller in Predictive Low Glucose Suspend ModeDevice
The artificial pancreas controller contains an algorithm for managing blood glucose in people with type 1 diabetes which includes an exercise detection component. The new algorithm will have 3 modes: a single hormone closed-loop insulin only mode, a dual-hormone closed-loop insulin and glucagon mode and an insulin only mode with predictive low glucose suspend. Closed-loop Artificial Pancreas Controller includes insulin delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to one Tandem t:slim insulin pumps filled with insulin.
| Study group | Role | What they receive |
|---|---|---|
| Predictive Low Glucose Suspend Arm | Experimental | Subjects will undergo an 84 hour study with 24 hours inpatient and 60 hour outpatient. The predictive low glucose suspend system will run through the artificial pancreas controller in predictive low glucose suspend mode and utilize the patient's optimized basal rates, correction factor, and carb ratio, but it will have the additional safety net of the pump suspending insulin when it predicts a hypoglycemic event. Receives: Device: Artificial Pancreas Controller in Predictive Low Glucose Suspend Mode |
| Dual Hormone Closed-loop Arm | Experimental | Subjects will undergo an 84 hour study with 24 hours inpatient and 60 hour outpatient using the closed-loop artificial pancreas controller in dual hormone mode to manage blood sugar that includes an exercise detection component that includes a reduction in insulin delivery and an increase in glucagon delivery upon detection. Receives: Device: Artificial Pancreas Controller in Dual Hormone Mode |
| Single Hormone Closed-loop Arm | Experimental | Subjects will undergo an 84 hour study with 24 hours inpatient and 60 hour outpatient using the closed-loop artificial pancreas controller in single hormone mode to manage blood sugar that includes an exercise detection component that includes a reduction in insulin delivery upon detection. Receives: Device: Artificial Pancreas Controller in Single Hormone Mode |
| Sensor Augmented Pump Therapy arm | Active comparator | Subjects will undergo an 84 hour study with 24 hours inpatient and 60 hour outpatient with subject's insulin pump and glucose sensor, if he/she typically uses one. Subjects will still wear a heart rate monitor uploading to a smart phone. Receives: Device: Subject's insulin pump |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of Time With Sensed Glucose < 3.9 mmol/L
Assess the percent of time that the Dexcom G4 Share reported sensor glucose values less than 3.9 mmol/L using Dexcom sensor downloads across all four arms.
Measured: entire 84 hour study
Percent of Time With Sensed Glucose < 3.9 mmol/L
Assess the percent of time that the Dexcom G4 Share reported sensor glucose values less than 3.9 mmol/L using Dexcom sensor downloads across all four arms.
Measured: From 14:00-18:00 for each 12 hour inpatient visit
Percent of Time With Sensed Glucose Between 3.9-10 mmol/L
Assess the percent of time that the Dexcom G4 Share reported sensor glucose values between 3.9-10 mmol/L using Dexcom sensor downloads across all four arms.
Measured: entire 84 hour study
Percent of Time With Sensed Glucose Between 3.9-10 mmol/L
Assess the percent of time that the Dexcom G4 Share reported sensor glucose values between 3.9-10 mmol/L using Dexcom sensor downloads across all four arms.
Measured: From 14:00-18:00 for each 12 hour inpatient visit
Secondary outcomes (8)
Mean Sensed Glucose
Assess the mean sensor glucose using Dexcom sensor downloads across all four arms.
Measured: entire 84 hour study
Number of Carbohydrate Treatments
Assess the number of rescue carbohydrate treatments per day across all four arms.
Measured: entire 84 hour study
Percent of Time With Sensed Glucose < 3.0 mmol/L
Assess the percent of time that the Dexcom G4 Share reported sensor glucose values less than 3.0 mmol/L using Dexcom sensor downloads across all four arms.
Measured: entire 84 hour study
Percent of Time With Sensed Glucose > 10 mmol/L
Assess the percent of time that the Dexcom G4 Share reported sensor glucose values greater than 10 mmol/L using Dexcom sensor downloads across all four arms
Measured: entire 84 hour study
Number of Events With Capillary Blood Glucose < 3.9 mmol/L
Assess number of events with capillary blood glucose < 3.9 mmol/L using downloads from a Contour Next blood glucose meter across all four arms. .
Measured: entire 84 hour study
Number of Events With Capillary Blood Glucose < 3.0 mmol/L
Assess number of events with capillary blood glucose < 3.0 mmol/L using downloads from a Contour Next blood glucose meter across all four arms.
Measured: entire 84 hour study
Mean Amount of Insulin Delivered
Assess the average amount of insulin delivered per day in units/kg as documented through the artificial pancreas controller across all four arms.
Measured: 24 hours
Mean Amount of Glucagon Delivered
Assess the average amount of insulin delivered per day in units/kg as documented through the artificial pancreas controller in dual hormone arm.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2016 (estimated)
- Study startOct 2016
- Primary completionAug 2017
- Study completion31 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jessica Castle, Oregon Health and Science University
- Investigators
- Jessica Castle, MD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02862730
- Sponsor's protocol ID
- 15590
- Status last verified
- Aug 2018
- First submitted
- 28 Jul 2016
- Last updated
- 14 Sep 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Castle JR, El Youssef J, Wilson LM, Reddy R, Resalat N, Branigan D, Ramsey K, Leitschuh J, Rajhbeharrysingh U, Senf B, Sugerman SM, Gabo V, Jacobs PG. Randomized Outpatient Trial of Single- and Dual-Hormone Closed-Loop Systems That Adapt to Exercise Using Wearable Sensors. Diabetes Care. 2018 Jul;41(7):1471-1477. doi: 10.2337/dc18-0228. Epub 2018 May 11.
PubMed 29752345
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Four-way, Cross-over Outpatient Study to Assess the Efficacy of a Dual-hormone Versus Insulin Alone Closed-loop System With Exercise Detection vs a Predictive Low Glucose Suspend System vs Current Care
- ClinicalTrials.gov ID
- NCT02862730
- Acronym / sponsor ID
- 15590
- Conditions
- Type 1 Diabetes
- Keywords
- diabetes, closed-loop, dual hormone, exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- Oct 2016 (actual)
- Primary completion
- Aug 2017 (actual)
- Study completion
- 31 Jan 2018 (actual)
- First posted
- 11 Aug 2016 (estimated)
- Results
- Posted 17 May 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Closed-loop systems are an emerging technology that automate hormone delivery. They are quickly paving the way to revolutionize the treatment of type 1 diabetes. Several categories have emerged: dual-hormone (insulin and glucagon) closed-loop systems and closed-loop systems with insulin only, one variety of which is the low glucose suspend safety feature now available from Medtronic (MiniMed 530G with Enlite). The study described within this protocol is designed to test the efficacy of a new closed-loop algorithm for managing blood glucose in people with type 1 diabetes before and after exercise. The new algorithm will have 3 modes: a single hormone insulin only mode, a dual-hormone insulin and glucagon mode and an insulin only mode with predictive low glucose suspend, all with an exercise detection algorithm. The purpose of this study is to determine whether a dual hormone AP with an exercise detection algorithm outperforms both single hormone AP and a low glucose suspend algorithm and sensor augmented pump therapy using the subject's own insulin pump.
Detailed description
Subjects will undergo four approximately 84 hour studies. The first day of each study will be an approximately 12 hour inpatient visit to include activities of daily living and an exercise period with 2 days spent as an outpatient. The subject will come back to the research center on the fourth day to complete another approximately 12 hour inpatient visit to include activities of daily living and an exercise period followed by removal of all devices. In randomized order, subjects will have glucose controlled using the following systems: 1) dual-hormone closed-loop system, 2) insulin only closed-loop system, 3) predictive low glucose suspend system and 4) sensor augmented pump therapy with subject using their own insulin and insulin pump. Both of the closed-loop system algorithms have an exercise detection algorithm that uses inputs from a heart rate monitor and accelerometer, the Zephyrlife BioPatch. After exercise detection, insulin is turned off for the first 30 minutes, the total insulin infusion rate is adjusted by an exercise multiplier, and for the dual-hormone system, the target glucose for glucagon is increased along with the maximum dose of glucagon allowed. The predictive low glucose suspend system will utilize the patient's optimized basal rates, correction factor, and carb ratio. The patient will bolus for meals and hyperglycemia as usual under PLGS, but will have the additional safety net of the pump suspending insulin when it predicts a hypoglycemic event. The Dexcom CGM system and the Tandem t:slim pumps will be used for all three intervention visits.
Subjects will arrive at the CTRC at 7am at the start of intervention visits. Subjects will eat breakfast, lunch and dinner in the research center. Subjects will eat breakfast at 8:30am. After breakfast, subjects will complete activities of daily living (sitting on a chair, lying on a bed, washing dishes, sweeping the floor, etc.). Subjects will eat lunch at 12pm. Subjects will exercise for 45 minutes on a treadmill around 2pm. Subjects will eat dinner at 6pm and be discharged. The subject will then go home for Day 2 and Day 3 and return on Day 4 to complete another 12 hour inpatient visit with the schedule of activities identical to Day 1.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Predictive Low Glucose Suspend Arm | Experimental | Device: Artificial Pancreas Controller in Predictive Low Glucose Suspend ModeSubjects will undergo an 84 hour study with 24 hours inpatient and 60 hour outpatient. The predictive low glucose suspend system will run through the artificial pancreas controller in predictive low glucose suspend mode and utilize the patient's optimized basal rates, correction factor, and carb ratio, but it will have the additional safety net of the pump suspending insulin when it predicts a hypoglycemic event. |
| Dual Hormone Closed-loop Arm | Experimental | Device: Artificial Pancreas Controller in Dual Hormone ModeSubjects will undergo an 84 hour study with 24 hours inpatient and 60 hour outpatient using the closed-loop artificial pancreas controller in dual hormone mode to manage blood sugar that includes an exercise detection component that includes a reduction in insulin delivery and an increase in glucagon delivery upon detection. |
| Single Hormone Closed-loop Arm | Experimental | Device: Artificial Pancreas Controller in Single Hormone ModeSubjects will undergo an 84 hour study with 24 hours inpatient and 60 hour outpatient using the closed-loop artificial pancreas controller in single hormone mode to manage blood sugar that includes an exercise detection component that includes a reduction in insulin delivery upon detection. |
| Sensor Augmented Pump Therapy arm | Active comparator | Device: Subject's insulin pumpSubjects will undergo an 84 hour study with 24 hours inpatient and 60 hour outpatient with subject's insulin pump and glucose sensor, if he/she typically uses one. Subjects will still wear a heart rate monitor uploading to a smart phone. |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Diagnosis of type 1 diabetes mellitus for at least 1 year.
- Physically willing and able to perform 45 min of exercise (as determined by the investigator after reviewing the subjects activity level)
- Current use of an insulin pump.
- Lives with another person age 18 or older who will be present while subject exercises at home and that can attend the training on using the system with the subject.
- Lives within 20 miles of OHSU.
Key exclusion criteria (33 listed)
- Female of childbearing potential who is pregnant or intending to become pregnant or breast-feeding, or is not using adequate contraceptive methods. Acceptable contraception includes birth control pill / patch / vaginal ring, Depo-Provera, Norplant, an IUD, the double barrier method (the woman uses a diaphragm and spermicide and the man uses a condom), or abstinence.
- Any cardiovascular disease, defined as a clinically significant EKG abnormality at the time of screening or any history of: stroke, heart failure, myocardial infarction, angina pectoris, or coronary arterial bypass graft or angioplasty. Diagnosis of 2nd or 3rd degree heart block or any non-physiological arrhythmia judged by the investigator to be exclusionary.
- Renal insufficiency (GFR < 60 ml/min, using the MDRD equation as report by the OHSU laboratory).
- Liver failure, cirrhosis, or any other liver disease that compromises liver function as determined by the investigator.
- Hematocrit of less than or equal to 34%.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Artificial Pancreas Controller in Dual Hormone ModeAlso: APCThe artificial pancreas controller contains an algorithm for managing blood glucose in people with type 1 diabetes which includes an exercise detection component. The new algorithm will have 3 modes: a single hormone closed-loop insulin only mode, a dual-hormone closed-loop insulin and glucagon mode and an insulin only mode with predictive low glucose suspend. Closed-loop Artificial Pancreas Controller includes insulin and glucagon delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to two Tandem t:slim insulin pumps, one filled with insulin and one with glucagon. | Device | Dual Hormone Closed-loop Arm |
| Subject's insulin pumpSubject will continue on their subcutaneous delivery of insulin on his/her own insulin pump using their own basal rates and carb ratios for meal boluses, managing their blood sugar as they normally would. | Device | Sensor Augmented Pump Therapy arm |
| Artificial Pancreas Controller in Single Hormone ModeThe artificial pancreas controller contains an algorithm for managing blood glucose in people with type 1 diabetes which includes an exercise detection component. The new algorithm will have 3 modes: a single hormone closed-loop insulin only mode, a dual-hormone closed-loop insulin and glucagon mode and an insulin only mode with predictive low glucose suspend. Closed-loop Artificial Pancreas Controller includes insulin delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to one Tandem t:slim insulin pumps filled with insulin. | Device | Single Hormone Closed-loop Arm |
| Artificial Pancreas Controller in Predictive Low Glucose Suspend ModeThe artificial pancreas controller contains an algorithm for managing blood glucose in people with type 1 diabetes which includes an exercise detection component. The new algorithm will have 3 modes: a single hormone closed-loop insulin only mode, a dual-hormone closed-loop insulin and glucagon mode and an insulin only mode with predictive low glucose suspend. Closed-loop Artificial Pancreas Controller includes insulin delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to one Tandem t:slim insulin pumps filled with insulin. | Device | Predictive Low Glucose Suspend Arm |
Primary outcome
Percent of Time With Sensed Glucose < 3.9 mmol/L
Time frame: entire 84 hour study
Assess the percent of time that the Dexcom G4 Share reported sensor glucose values less than 3.9 mmol/L using Dexcom sensor downloads across all four arms.
Percent of Time With Sensed Glucose < 3.9 mmol/L
Time frame: From 14:00-18:00 for each 12 hour inpatient visit
Assess the percent of time that the Dexcom G4 Share reported sensor glucose values less than 3.9 mmol/L using Dexcom sensor downloads across all four arms.
Percent of Time With Sensed Glucose Between 3.9-10 mmol/L
Time frame: entire 84 hour study
Assess the percent of time that the Dexcom G4 Share reported sensor glucose values between 3.9-10 mmol/L using Dexcom sensor downloads across all four arms.
Percent of Time With Sensed Glucose Between 3.9-10 mmol/L
Time frame: From 14:00-18:00 for each 12 hour inpatient visit
Assess the percent of time that the Dexcom G4 Share reported sensor glucose values between 3.9-10 mmol/L using Dexcom sensor downloads across all four arms.
8 secondary outcomes
Mean Sensed Glucose
Time frame: entire 84 hour study
Number of Carbohydrate Treatments
Time frame: entire 84 hour study
Percent of Time With Sensed Glucose < 3.0 mmol/L
Time frame: entire 84 hour study
Percent of Time With Sensed Glucose > 10 mmol/L
Time frame: entire 84 hour study
Number of Events With Capillary Blood Glucose < 3.9 mmol/L
Time frame: entire 84 hour study
Number of Events With Capillary Blood Glucose < 3.0 mmol/L
Time frame: entire 84 hour study
Mean Amount of Insulin Delivered
Time frame: 24 hours
Mean Amount of Glucagon Delivered
Time frame: 24 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29752345Castle JR, El Youssef J, Wilson LM, Reddy R, Resalat N, Branigan D, Ramsey K, Leitschuh J, Rajhbeharrysingh U, Senf B, Sugerman SM, Gabo V, Jacobs PG. Randomized Outpatient Trial of Single- and Dual-Hormone Closed-Loop Systems That Adapt to Exercise Using Wearable Sensors. Diabetes Care. 2018 Jul;41(7):1471-1477. doi: 10.2337/dc18-0228. Epub 2018 May 11.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jessica Castle, MD principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Subject's insulin pump in people with Type 1 Diabetes, run by Oregon Health and Science University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 May 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of Time With Sensed Glucose < 3.9 mmol/L (time frame: entire 84 hour study). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02862730, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2018.